Kornimate/medical-research-clean huggingface dataset:
pemvin vs vin in previously treated metastatic breast cancer

Conditions: Breast Neoplasms

Summary: pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and mesothelioma. there are several clinical studies of pemetrexed in breast cancer, but these are largely done before the wide use of premedication (steroid and vitamin b12) for pemetrexed. moreover, it has not been studied in combination with vinorelbine, which is a commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer. this is a randomized phase ii study of pemetrexed plus vinorelbine versus vinorelbine in patients with recurrent or metastatic breast cancer previously treated with or resistant to an anthracycline and taxane.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed, recurrent or metastatic breast cancer 2. her2-negative 3. ecog ps 0-2 4. age ≥ 20 years 5. anthracycline- and taxane-pretreated 6. wash-out period of 3 weeks for cytotoxic chemotherapy 7. wash-out period of 2 weeks for hormone therapy or radiotherapy 8. measurable or non-measurable lesions by recist v1.1 9. adequate hematological functions : anc ≥1,500/mm3, platelet ≥100,000/mm3, hb≥ 9g/dl 10. adequate liver functions 11. adequate renal functions : scr≤1.5mg/dl 12. subjects willing to follow study protocol 13. informed consent before study entry exclusion criteria: 1. more than 3 lines of chemotherapy for metastatic breast cancer 2. pregnant or breastfeeding women 3. previous exposure to pemetrexed or vinorelbine 4. neuropathy (grade 2 or more) 5. symptomatic cns metastasis 6. history of malignant disease within 5 years (except for cured basal cell cancer or squamous cell cancer of skin, cured thyroid cancer, in-situ cervical cancer) 7. hypersensitivity to study medication or related drugs 8. concomitant vaccination for yellow fever
gastrointestinal microbiome study of appendiceal cancer

Conditions: Pseudomyxoma Peritonei; Appendiceal Neoplasm; Cancer, Appendiceal

Summary: this study analyzes the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (crs/hipec). participants will provide fecal samples pre- and post-operatively.

analysis of the human microbiome is an attempt to define how changes in the human microbiome are associated with health or disease. eligible participants scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (crs/hipec) for appendiceal cancer will provide fecal samples pre- and post-operatively. investigators will analyze potential changes in the gastrointestinal microbiome and make comparisons to an age-matched healthy sample.

Eligibility criteria:
inclusion criteria: * diagnosis of appendiceal cancer with peritoneal spread * candidate for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (crs/hipec) * ≥18 and ≤ 80 years of age * eastern cooperative oncology group performance status score of ≤2/karnofsky performance status (kps) ≥70% * signed institutional review board approved informed consent exclusion criteria: * \<18 years of age * pregnant women * concurrent severe medical problems unrelated to malignancy

Keywords: cytoreductive surgery hyperthermic intraperitoneal chemotherapy microbiome
bioboosti device for insomnia treatment

Conditions: Insomnia

Summary: the purpose of this study is to determine the effects of the bioboosti device on sleep for patients who have been diagnosed with insomnia.

insomnia is a common health complaint that is associated with discomfort, loss of productivity, poor health and higher use of healthcare. the use of non-pharmacologic treatments for insomnia has gained much attention in recent years. the investigators are conducting this research because a safe, non-pharmacologic treatment would benefit patients with insomnia, and to see if the bioboosti device is an effective treatment for insomnia. subjects will include patients from the clinics who have the diagnosis of insomnia. study staff will notify the treating physician of a potential subject. if the subject gives permission and would like to obtain more information, study staff will approach them and provide them with the consent form to review. study staff may also contact them by phone to explain the study and recruit. subjects will be asked to make 5 visits: visit 1-- consent form, physical exam, vitals, pregnancy test, sleep log visit 2-- sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of eeg visit 3-- remove eeg, beginning of treatment with bioboosti device, sleep log treatment phase-- subjects use the bioboosti at home for two weeks visit 4-- return of bioboosti, sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of eeg visit 5-- remove eeg, collect sleep logs

Eligibility criteria:
inclusion criteria: * patients with insomnia exclusion criteria: * untreated moderate or severe sleep apnea * major circadian rhythm disorder * pregnant women * breastfeeding * cardiac pacemaker * cancer * severe conditions related to heart, brain, kidney and hematopoietic system * severe/unstable angina pectoris * arteria coronaria/ peripheral arterial bypass graft * acute congestive heart failure * renal insufficiency * mechanical intestinal obstruction * any electrical devices

Keywords: insomnia sleep bioboosti biomobie device
evaluation of ray1225 in adult participants who have obesity or are overweight

Conditions: Obesity

Summary: the primary objective of this study is to demonstrate that ray1225 is superior to placebo for percent change in body weight.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. body mass index ≥ 28 kg/m2 or ≥24kg/m² to \<28 kg/m2 with at least 1 of the following weight-related comorbidities: a) systolic blood pressure ≥130 mmhg or diastolic blood pressure ≥85 mmhg, or the use of at least one antihypertensive medication to maintain normal blood pressure;b) fasting triglycerides (tg) ≥1.70 mmol/l, fasting low-density lipoprotein cholesterol (ldl-c) ≥4.1 mmol/l, fasting high-density lipoprotein cholesterol (hdl-c) \<1.04 mmol/l, or the need for at least one lipid-lowering treatment to maintain normal lipid levels; c) obstructive sleep apnea syndrome; d) fatty liver; e) cardiovascular disease; e) polycystic ovary syndrome. 3. history of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. exclusion criteria: 1. obesity known to be caused by monogenic mutations, other diseases, or medications. 2. family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2. 3. a history of moderate to severe depression at any time in the past or a score of ≥15 on the phq-9 questionnaire at screening; a history of bipolar disorder, schizophrenia, or other severe psychiatric disorders. 4. a history of organ transplantation (excluding corneal transplant), or being currently prepared to undergo organ transplantation. 5. plans to quit smoking during the study period 6. allergic constitution (allergic to multiple medications or foods), or those known to be allergic to ray1225, glp-1 receptor agonists, or glp-1 related drugs.
efficacy of probiotics on iron status during pregnancy

Conditions: Prevention of Iron Deficiency

Summary: determine the effect of probiotics on improving iron status in a population of healthy, pregnant women.


Eligibility criteria:
inclusion criteria: * healthy, pregnant women, aged 18-42 years, with a singleton gestation * inclusion at 10-12 weeks of gestation * bmi ≥ 18 and ≤ 30 at baseline * provide signed and dated informed consent form * willing to comply with all study procedures exclusion criteria: * serum ferritin level \<20 µg/l or hb\<110 g/l at baseline (visit 1) * chronic diseases associated with anemia * known thalassemia * hyperemesis gravidarum * chronic gastrointestinal disease (inflammable bowel diseases; crohn's disease, ulcerative colitis; diarrheal disease) * known gluten intolerance, lactose intolerance, milk protein allergy * taking antibiotics within four weeks before inclusion * blood or plasma donation within three (3) months prior to baseline * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * smoking or use of nicotine-containing products (currently or during the last three \[3\] months) * history of alcohol abuse, or excessive intake of alcohol, as judged by the investigator * hypersensitivity to any of the ingredients in the study products * any other reason for exclusion, as judged by the investigator
molecular effects of a multi-carotenoids (mcs) new agent on prostate cancer chemoprevention

Conditions: Prostate Cancer

Summary: this is to prospectively investigate whether the chemopreventive agent, mcs, may favorably alter biomarker expression, whether serum carotenoids levels are associated with biomarkers levels, and whether the alterations of biomarker expression may reflect the cancer risk as shown by cancer incidence at the end of the clinical trial.

many epidemiological studies have shown that nutrients or elements from tomato or other plants, including lycopene and multi-carotenoids, may reduce the risk of prostate cancer, especially those of lethal cancer. studies have also shown that multi-carotenoids may reduce serum psa levels in prostate cancer patients. mcs is a patented, multi-carotenoids-rich, purely botanic agent. the investigators' previous phase ii and iii clinical trials (us fda and tfda, 600 subjects, studies finished, data in analysis) have shown that there were no mcs-related serious adverse events (sae). mcs may relieve urinary symptoms in men with bph and psa was reduced in men with elevated psa. so, the investigators are initiating a large multi-center phase ii randomized study (mcs-8, n=702) in taiwan, to study if mcs can reduce the risk of prostate cancer. high risk patients will be assigned to take oral daily 30, 15, and 0 (placebo) mg of mcs (1:1:1). the investigators will compare the cumulative prostate cancer incidence among groups and the change from baseline in serum carotenoids levels. (mcs-8-twn-ii clinicaltrials.gov nct02042807)

Eligibility criteria:
inclusion criteria: 1. subject of mcs-8 study inclusion criteria of mcs-8 study 1. high-risk subjects of prostate cancer. 2. male subject with age from 50 to 75 years old. 3. no active urinary tract infection (uti) or bacterial prostatitis. 4. subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (icf). exclusion criteria of mcs-8 study 1. subjects' elevated psa is deemed by the investigators solely to inflammation or infection of the prostate. 2. subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function. 3. subjects with a psa \> 10.0 ng/ml. 4. subjects with a history of prostate cancer. 5. subjects are currently taking or planning to take oral bile acid sequestrants. 6. subjects have malabsorption conditions. 7. subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period. 8. subjects are considered ineligible for the study as judged by the investigator. 9. other malignancies except non-melanoma skin cancer. 2. subject is eligible for mcs-8 study but did not sign up for the mcs-8 study. exclusion criteria: subject is not able to understand and willing to comply with the study procedures and has not signed the informed consent form (icf). note: (mcs-8-twn-ii clinicaltrials.gov nct02042807)

Keywords: prostate cancer chemoprevention biomarker
drug-drug interaction between pk101-001 and pk101-002

Conditions: Arthritis

Summary: to evaluate the drug-drug interaction of pk101-001 and pk101-002 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy adults ≥ 19 years of age (on the day of screening) * no congenital or chronic diseases and no abnormal signs determined by medical examinations * not abnormal or not clinical significant lab values * 90mmhg ≤ (sbp) ≤ 139mmhg, 60mmhg ≤ (dbp) ≤ 89mmhg * 18kg/(m)\^2 ≤ (bmi) ≤30kg/(m)\^2 exclusion criteria: * subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc) * subjects who were administered medications of prohibition within 10 days * heavy drinking within 30 days (female: over 14units/week, male:over 21units/week) * heavy smoker within 30 days (over 20 cigarettes per day) * subjects who previously participated in other clinical trials or bioequivalence test within 90 days * subjects who donated whole blood within 60 days or donated component blood within 14 days or received blood transfusion within 30 days * subjects who have hypersensitivity for investigational products
a study to test mk-0941 in adults with type 2 diabetes mellitus with inadequate glycemic control on insulin (mk-0941-018)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to test the effect mk-0941 as add-on therapy for adults taking insulin for type 2 diabetes.


Eligibility criteria:
inclusion criteria: * participant has type 2 diabetes mellitus exclusion criteria: * participant has a history of type 1 diabetes mellitus or ketoacidosis * participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication * participant has had surgery within 30 days of starting the study or has planned major surgery
cd19-targeting, 3rd generation car t cells for refractory b cells malignancy

Conditions: B-cell Leukemia; B-Cell Lymphoma

Summary: treatment of patients with b cell lymphoma or leukemia with two doses of cd19-targeting chimeric antigen receptor (car) t cells to evaluate for safety and efficacy.

treatment of patients with b cell lymphoma or leukemia with two doses of cd19-targeting chimeric antigen receptor (car) t cells to evaluate for safety and efficacy. the car consists of a cd19 targeting antibody scfv with three intracellular signaling domains derived from cd3 zeta, cd28 and 4-1bb. autologous t cells will be gene engineered with the car gene using a retrovirus vector. prior to t cell infusion, the patients will be subjected to preconditioning treatment. after the second infusion patients will be subjected to immunomodulatory treatment. after t cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of car t cells and efficacy. primary outcome: - registration of the safety profile such as inflammation, fever, pain, changes in blood pressure, pulse and other adverse events. weekly for the first 6 weeks, then at 3, 6, 9, 12, 15, 18, 21 and 24 months. secondary outcome: tumor response, car t cell persistence and immunological profile * determination of tumor size and the tumor marker cd19. * determination of the levels of circulating b cells. * determination of the level of car t cells (mrna and cells) in blood and biopsies. * determination of activation markers on car t cells such as cd107a. * determination of the presence of immunological markers in blood and biopsies. at 1 and 3 weeks then at 3, 6, 9, 12, 15, 18, 21 and 24 months.

Eligibility criteria:
inclusion criteria: 1. relapsed or refractory cd19+ b-cell lymphoma or leukemia with no other curative treatment option available. 2. measurable disease. 3. all ages 4. performance status ecog 0-2. 5. fertile females/males must consent to use contraceptives during participation of the trial. 6. signed informed consent. exclusion criteria: 1. any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. 2. patients with primary cns lymphoma. 3. known human immunodeficiency virus (hiv) infection. 4. active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis b virus (hbv) or active hepatitis c virus (hcv) infection. 5. other serious underlying medical conditions, which, in the investigator's judgment, could impair the ability of the patient to perform the treatment. 6. treatment with an investigational product within 30 days prior to enrollment, or at least 5 half-lives of that drug, which is longest. 7. pregnancy 8. patients that do not consent to that tissue and blood samples are stored in a biobank 9. patients whose cells cannot be manufactured.
effectiveness of exercise through video games in reducing fatigue among children with leukemia

Conditions: Fatigue; Childhood ALL

Summary: 40 children with cancer who fulfills the inclusion criteria will be included. participants will be recruited from king fahad children's cancer center, king fahad medical city and king khaled university hospital. after obtaining written formal consent, children will be randomly assigned to two groups, control and experimental. experimental group will play 60 minutes of wii physical activity games for three weeks, twice each week. while control group will receive conventional therapy. fatigue will be assessed using pediatric multidimensional fatigue scale- child proxy before, weekly during the study and after. functional capacity will be measured by six minute walk test before and after study duration, and physical activity will be repeatedly measured by godin-shephard leisure time physical activity questionnaire. all data will be analyzed using appropriate statistical analysis.

the intervention group: the investigator will: * handle accompanying each child to the play room, turn on the wii and ask the child to choose the game he/she prefers to play from the games provided by wii console that requires the movement of the whole body: upper, lower and trunk. * monitor the child while playing, helping with the instructions of the game if the child needs assistance as it is only provided in english from the console. * heart rate and oxygen saturation are planned to be measured every 15 minutes. the duration is designed to be 60 minutes per session, but the child is allowed to rest for the time needed during the session if he/she feels tired. or if the oxygen saturation of the child reaches 93. or the heart rate reaches the predicted maximum heart rate.

Eligibility criteria:
inclusion criteria: * diagnosed with leukemia, receiving chemotherapy, or off therapy within 6 months. exclusion criteria: * bone / pulmonary metastasis, having physical or cognitive disability preventing the child from being able to use the controller and board of the console.

Keywords: exergaming fatigue leukemia children
mechanism of allogeneic ucb therapy in cerebral palsy

Conditions: Cerebral Palsy; Child Development

Summary: in our prior study on the therapeutic mechanism of ucb, changes in cytokine levels were observed but the results are inconclusive and further studies on animal models and changes of protein expression before and after ucb therapy in the clinical settings are required. the changes in protein expression will be assessed by multiplex rt-pcr mrna assay. clinical efficacy of ucb therapy will be evaluated with various functional assessment tools. factors regarding ucb therapy (number of transplanted cells, hla matching status, serum level of immunosuppressant, etc.) and patient factors (age, functional status, etc.) will be analyzed for correlation with protein expression after ucb therapy. several target proteins for analysis are available. pentraxin and toll-like receptor (tlr) 4 are receptors modulating intrinsic immune reaction and was shown to have a significant correlation with clinical efficacy of stem cell therapy. ubiquitine is a regulatory protein that combines with the target protein and affects its degradation, interaction, localization and activation. the ubiquitine system controls total protein quantity for homeostasis and can be found in all tissues. deubiquitination (dub) enzyme down-regulates this ubiquitine and is known to modulate all cellular changes


Eligibility criteria:
inclusion criteria: 1. diagnosed with cerebral palsy 2. age of ≥10 months and ≤20 years 3. mismatch in hla-a, b, and dr ≤3, and total nucleated cell count ≥2x107/kg. if the cell count is less than given values, more than 2 units may be used. 4. voluntary decision to participation in the study with informed consent agreed and obtained from the subject's representative. 5. patient and/or representatives are both willing and capable of being hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry. 6. if the patient has participated in another clinical trial, at least 3 months should have passed since end of the study. exclusion criteria: 1. current aspiration pneumonia 2. known genetic disease 3. history of hypersensitivity reaction to any study drugs pertinent to the study 4. patient with severe convulsion disease who has clinical convulsion despite combination therapy with 3 or more agents 5. uncontrolled hypertension defined as systolic blood pressure \>115 mmhg and/or diastolic blood pressure \>70 mmhg 6. hepatic impairment defined as asparate aminotransferase (ast) \>55 iu/l and/or alanine aminotrasferase (alt) \>45 iu/l 7. renal impairment defined as creatinine (cr) ≥1.3 mg/dl 8. presence of diagnosed or suspected malignant tumor and/or hematologic malignancy 9. non-compliance with study visits specified in the protocol or poor compliance of care-giver. 10. any factors not specified above that the principal investigator determines medically inadequate for participation in this study.

Keywords: umbilical cord blood transplantation cytokine changes
defra questionnaire as an anamnestic form

Conditions: Osteoporosis

Summary: the defra questionnaire is a new validated algorithm derived from frax. here we use the defra as a "primary anamnestic from" to identify subjects at risk of osteoporosis in a population never screened before and never treated for this disease.

there is an increasing recognition that the management of osteoporosis requires the characterization of fracture risk to be based on absolute risk rather than single measures such as bone mineral density (bmd). however, the threshold for pharmacological intervention for osteoporosis remains controversial. the aim of the present project is to perform a large scale study to identify subjects at risk of osteoporosis by administering the defra questionnaire in a population never screened or treated before for osteoporosis. defra questionnaire will be administered before and after dexa scanning, to further validate the questionnaire and to highlight the predictive value of this protocol as a tool to screen the general population.

Eligibility criteria:
inclusion criteria: * age: 50 to 70 years * no overt pathologies * never screened before for osteoporosis * no prior use of drugs for osteoporosis * signed informed consent form exclusion criteria: * overt pathologies (cancer, neurodegenerative diseases, renal or hepatic insufficiency) * use of the following drugs: cortisones, loop diuretics, antiepileptic drugs, aromatase inhibitors, dicoumarols, thyroxin in suppressive therapy, antiosteoporosis drugs) * patients who underwent radiation therapy * hypercalcemia or alterations of the phospho-calcic metabolism * patients with metabolic diseases of the bone (including hyperparathyroidism or paget disease)